Key Inclusion Criteria:
- Participant must have epilepsy, as determined by the investigator, and be taking
clobazam (CLB).
- Participant must have a documented magnetic resonance imaging/computerized tomography
of the brain ruling out a progressive neurologic condition.
- Participant must be taking CLB and no more than 2 other antiepileptic drugs (AEDs)
during the course of the trial.
Key Exclusion Criteria:
- Patient has clinically significant unstable medical conditions other than epilepsy.
- Participants on CLB at doses above 20 mg per day.
- Participants taking CLB intermittently as rescue medication.
- Participant has a history of symptoms related to a drop in blood pressure due to
postural changes (e.g., dizziness, light-headedness, blurred vision, palpitations,
weakness, syncope).
- Participant has any history of suicidal behavior or any suicidal ideation of type 4
or 5 on the C-SSRS in the last month or at the screening visit of the blinded phase
of the trial.
- Participant has had clinically relevant symptoms or a clinically significant illness
in the 4 weeks prior to screening or enrollment in the blinded phase of the trial,
other than epilepsy.
- Participant is currently using or has in the past used recreational or medicinal
cannabis, or synthetic cannabinoid-based medications (including Sativex®) within the
3 months prior to trial entry.
- Participant has any known or suspected history of any drug abuse or addiction.
- Participant is unwilling to abstain from recreational or medicinal cannabis, or
synthetic cannabinoid based medications (including Sativex) for the duration for the
trial.
- Participant has any known or suspected hypersensitivity to cannabinoids or any of the
excipients of the Investigational Medicinal Product (IMP), e.g., sesame oil.